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Last Updated: September 30, 2022

PREPOPIK Drug Patent Profile


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Which patents cover Prepopik, and when can generic versions of Prepopik launch?

Prepopik is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five countries.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

DrugPatentWatch® Generic Entry Outlook for Prepopik

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for PREPOPIK
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PREPOPIK Oral Solution citric acid; magnesium oxide; sodium picosulfate 10 mg, 3.5 g, and 12 g 202535 1 2014-05-21

US Patents and Regulatory Information for PREPOPIK

PREPOPIK is protected by two US patents.

Patents protecting PREPOPIK

Granular compositions of sodium picosulphate and potassium bicarbonate and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Granular compositions of magnesium oxide and citric acid and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PREPOPIK

When does loss-of-exclusivity occur for PREPOPIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08309287
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0818541
Estimated Expiration: See Plans and Pricing

Canada

Patent: 02152
Estimated Expiration: See Plans and Pricing

China

Patent: 1406457
Estimated Expiration: See Plans and Pricing

Patent: 1820859
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180215
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 07526
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 07526
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 38174
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4500
Estimated Expiration: See Plans and Pricing

Japan

Patent: 54873
Estimated Expiration: See Plans and Pricing

Patent: 11500549
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 06
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 07526
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10003588
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3899
Estimated Expiration: See Plans and Pricing

Poland

Patent: 07526
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 07526
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 73332
Estimated Expiration: See Plans and Pricing

Patent: 10112483
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 14
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 07526
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1002131
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1330096
Estimated Expiration: See Plans and Pricing

Patent: 1381263
Estimated Expiration: See Plans and Pricing

Patent: 100072020
Estimated Expiration: See Plans and Pricing

Patent: 130105757
Estimated Expiration: See Plans and Pricing

Spain

Patent: 59716
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 18352
Estimated Expiration: See Plans and Pricing

Patent: 0924759
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 05953
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREPOPIK around the world.

Country Patent Number Title Estimated Expiration
Mexico 2010003588 PROCESO PARA LA MANUFACTURA DE UN PRODUCTO FARMACEUTICO. (PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT.) See Plans and Pricing
European Patent Office 2207526 PROCÉDÉ DE FABRICATION D'UN PRODUIT PHARMACEUTIQUE CONTENANT DE L'ACIDE CITRIQUE, DE L'OXYDE DE MAGNÉSIUM, DU BICARBONATE DE POTASSIUM ET DU PICOSULFATE DE SODIUM, COMPOSITION PHARMACEUTIQUE CONTENANT DES GRANULES ET LEUR PRODUIT INTERMEDIAIRE (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF) See Plans and Pricing
Croatia P20180215 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.